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Technical Writer

  • Job reference: 930649
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 31/03/2020

Orion Group Life Sciences have an exciting opportunity for a Technical Writer for our Multinational Medical Devices client based in the Limerick area on an initial 8-month contract.


Job Purpose

To provide support for the technical/validation documentation and support activities within quality engineering to ensure that all activities associated with change control and general Engineering support tasks are completed in a fully compliant manner in accordance with the requirements of client Validation/Quality Policies and Procedures. The role requires collaboration with Engineering and Operations to ensure client Validation/Quality Policies and Procedures are maintained.


Main Responsibilities of the role

  • Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials
  • To aid with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively to meet both the TRB and CCB requirements and timelines
  • Help coordinate FMEA sessions with Quality Engineering as needed
  • Assist with attachment and upload of deliverables associated with change control
  • Help with non-critical Validation execution under direction of Engineering
  • Assist with purchasing and spare parts ordering
  • Support Engineering with planning and department development
  • Provide training on quality systems
  • Manages and monitors the change control metrics
  • Ensure accuracy and consistency of the technical/validation documentation
  • Ensure all quality/validation documents are authorized and appropriate compliance approval is gained
  • Update procedures

Desired Experience and Background of the successful candidate

  • Qualification in an appropriate discipline (e.g. Science or Engineering or Information systems)
  • Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectation
  • Experience working in a regulated environment would be an advantage
  • Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems
  • Excellent verbal and written communication skills
  • Establishes and manages engagement objectives and expectations
  • Works independently and/or within team to accomplish job objectives
  • Establishes and follows priorities
  • Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process
  • Builds cross functional and cross-departmental support, fostering overall effectiveness

#medicaldevices #medical #device #13485 #multinational #product #implant #technicalwriting #GMP #compliance #validation

For more information on this role, call Shane O' Neill on +353212063407 or email shane.oneill@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930649


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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